Evaluating the Efficacy of Digestive Aid in Functional Dyspepsia: A Randomized Double Blind Control Trial

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Functional Dyspepsia (FD) is diagnosed in the presence of bothersome epigastric pain or burning, early satiation and/or postprandial fullness of greater than 8 weeks duration, in the absence of alarm signs. Alarm signs include weight loss, gastrointestinal bleeding, anemia, dysphagia, and family history of upper gastrointestinal malignancies. FD is a common gastrointestinal complaint. It's prevalence in Iranian population is reported to be from 2.2% to 29.9% (1). FD should be introduced as a disorder of gut-brain interaction (DGBI), together with a simple account of the gut-brain axis and how this is impacted by diet, stress, cognitive, behavioral and emotional responses to symptoms and post-infective changes. Histamine-2-receptor antagonists, proton pump inhibitors, and prokinetics are introduced as the first line classic treatment in FD. (2) Tricyclic antidepressants (TCAs) used as gut-brain neuromodulators are an efficacious second-line treatment for FD. (2) Antipsychotics, such as sulpiride 100 mg four times a day or levosulpiride 25 mg three times a day, may be efficacious as a second-line treatment for FD. Tandospirone, Pregabalin, Mirtazapine are among the suggested second line pharmachological therapy. (2) FD expresses a spectrum of various upper gastrointestinal complaints. Epigastric pain, retrosternal pain, regurgitation, nausea, vomiting, belching, dysphagia, and early satiety are among the most frequent symptoms. Therefore, a combination of medications might be needed to alleviate the patients' discomfort. The pharmaceutics have proposed the package of medications to increase the patient compliance. Digestive Aid is a cocktail that contains Marshmallow, Ginger, Gentian, Fennel, Peppermint, and Anise oil. It is widely used by physicians to control dyspeptic symptoms. There are studies on human and animals that showed the efficacy of mentioned herbal supplements on dyspepsia. To the best of our knowledge there is no study about the efficacy of Digestive Aid in the dyspeptic patients. This trial is conducted to evaluate the efficacy of mentioned product in alleviating the symptoms in FD in a sample of the Iranian patients.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• The new onset dyspeptic patients

Locations
Other Locations
Islamic Republic of Iran
Sina Hospital
RECRUITING
Tehran
Contact Information
Primary
Raika Jamali, Professor
jamalira@tums.ac.ir
+98-21-63120000
Time Frame
Start Date: 2025-04-15
Estimated Completion Date: 2026-03
Participants
Target number of participants: 50
Treatments
Experimental: Digestive Aid
Treatment with Digestive Aid
Placebo_comparator: Placebo
Treatment with placebo
Related Therapeutic Areas
Sponsors
Leads: Tehran University of Medical Sciences
Collaborators: Darman Yab Darou Co.

This content was sourced from clinicaltrials.gov